Catalog Number

120019

Brand Name

HEWSON LIGAMENT BUTTON

Version/Model Number

120019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGS

Product Code Name

RETENTION DEVICE, SUTURE

Public Device Record Key

8c80fc1e-4259-4125-8ec0-969d9adeabc3

Public Version Date

January 08, 2019

Public Version Number

3

DI Record Publish Date

November 13, 2017

Package DI Number

23596010059721

Quantity per Package

6

Contains DI Package

03596010059727

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX